A Randomized, Double Blind, Placebo Controlled Trial L-carnitine and Piracetam in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

Phase 3

Withdrawn

• Conditions: Postpoliomyelitis Syndrome
• Interventions: Drug: Placebo; Drug: L-carnitine and piracetam

• Registration Number: NCT01549847
• Lead Sponsor: Biolab Sanus Farmaceutica

Brief Summary

This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Primary Completion: 2013-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with Postpoliomyelitis Syndrome diagnosis confirmed over a year;
• Electromyography test compatible with poliomyelitis;
• Preserved ability to swallow medication;
• Oral communication ability preserved;
• Preserved ability to perform pedaling test in at least one lower limb affected by Postpoliomyelitis Syndrome;
• Ability to understand information about the study and to document the decision about participating in the trial by signing the Informed Consent Form.

Exclusion Criteria

• History of intolerance to L-carnitine or piracetam;
• Treatment with L-carnitine during the past 3 months;
• Treatment with piracetam or any other nootropics pyrrolidone derivatives, during the past three months;
• Anemia (hemoglobin reference range - men 13 to 17 g/dL and women 12 to 15 g/dL);
• High level of glycated hemoglobin (> 7.0%);
• Electrolyte imbalance (hypokalaemia - reference potassium concentration range: 3.5 to 5.6 mmol / L);
• Renal failure (creatinine reference range: 0.70 to 1.50 mg/dL);
• Urinary tract infection;
• Thyroid dysfunction (reference range: free T4: 0.54 to 0.67 mg/dL and TSH reference range: 0.5 to 5.5 μUI/mL) or usual treatment with thyroid hormone supplementation;
• Cardiomyopathy;
• Uncontrolled hypertension;
• Known or suspected autoimmune disease;
• Confirmed pregnancy, or plans to get pregnant during the trial;
• Depression or bipolar affective disorders with moderate to severe episodes within the last twelve months;
• Insulin-dependent diabetes mellitus;
• Treatment with anticoagulant drugs over two weeks (including non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);
• Usual cocaine or alcohol use;
• Any other condition judged by the investigator as a possibility to interfere on the participant's decision to be part of the study or to accomplish investigation procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
L-carnitine and piracetam	L-carnitine and piracetam	-

Primary Outcome Measures

Name	Time	Method
Changes in fatigue	26 weeks
Changes in Muscle Weakness	26 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in muscle pain	26 weeks
Changes in daytime sleepiness	26 weeks
Changes in quality of life	26 weeks
Changes in daily function	26 weeks
Changes in depressive mood	26 weeks
Changes in oxidative capacity in skeletal muscle	26 weeks
Occurrence of adverse events	26 weeks

Trial Locations

Locations (1)

UNIFESP; 🇧🇷 São Paulo, SP, Brazil